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endocard pacing lead-long length pl203
Daig
Summary: The Endocard Pacing Lead-Long Length PL203 is a cardiac pacing lead used in pacemaker implantation procedures. It is primarily utilized by cardiologists and electrophysiologists to maintain heart rhythm in patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K771567 ↗
Decision Date
September 14, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Endocard Pacing Lead-Long Length PL203, manufactured by Daig, received FDA clearance through the 510(k) pathway on September 14, 1977. It is classified as a Class III device under product code DTB.
What It Is
The Endocard Pacing Lead-Long Length PL203 is a specialized lead used in cardiac pacing systems. It is designed to be implanted in the heart to deliver electrical impulses that regulate heartbeats. The lead connects the pacemaker to the heart muscle, ensuring proper cardiac function in patients with arrhythmias or heart block.
Clinical Applications
This device is commonly used in the implantation of pacemakers, particularly in patients with bradycardia or heart block. It is typically utilized in hospital settings by cardiologists and electrophysiologists. The lead is suitable for adult patients who require long-term cardiac pacing to maintain an adequate heart rate.
Indications for Use
The Endocard Pacing Lead-Long Length PL203 is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker generators. Proper technique during implantation is crucial to ensure lead stability and optimal pacing function.
Frequently Asked Questions
What is Endocard Pacing Lead-Long Length PL203 used for?
It is used for cardiac pacing in patients with arrhythmias or heart block, helping to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing due to conditions like bradycardia or heart block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.